Accuracy of the Set Tidal Volume During Intraoperative Mechanical Ventilation

NCT06232915 | Withdrawn

• 1 other identifier: STUDY00003946
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

Prior to surgery the anesthesia team will be putting a breathing tube into the patient's windpipe and attaching it to a mechanical ventilator (breathing machine). This is to provide oxygen and anesthetic gas, and to help the child breathe while they're asleep. The ventilator also controls the amount of air that moves in and out of the lungs with each breath. This is called tidal volume and that amount is programmed into the machine by the anesthesia team. All of this is standard of care. As part of the study the investigators will put a small flow sensor between the patient's breathing tube and the tubing from the ventilator. This will measure the amount of air that is moving in and out of the breathing tube. The study team will record the tidal volume that is set on the ventilator and compare it to the airflow measured by the ventilator and the airflow measured by the sensor and see if there is a difference.

Conditions

Surgery; Mechanical Ventilation Pressure High

Outcome Measures

Primary Outcomes (2)

• Mean inspired tidal volume

  The average volume of air moved into the lungs over 25 breaths.

  Baseline

• Mean expired tidal volume

  The average volume of air moved out of the lungs over 25 breaths.

  Baseline

Study Arms (1)

Mechanical ventilation

Children requiring mechanical ventilation during a surgical procedure.

Procedure: Mechanical ventilation

Interventions

Mechanical ventilation PROCEDURE

Mechanical ventilation during surgery

Mechanical ventilation

Eligibility Criteria

• Age: 0 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Children requiring intraoperative mechanical ventilation.

You may qualify if:

• children aged 0-18 years having surgery at Nationwide Children's Hospital, in whom a cuffed ETT and mechanical ventilation will be used

You may not qualify if:

• children with preexisting airway anomalies or respiratory compromise will be excluded from the study.

Sponsors & Collaborators

• Joseph D. Tobias: lead

Study Sites (1)

Nationwide Children's Hospital

Columbus, Ohio, 43205, United States

Location

MeSH Terms

Interventions

Respiration, Artificial

Intervention Hierarchy (Ancestors)

Airway Management; Therapeutics; Resuscitation; Emergency Treatment; Respiratory Therapy

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Chief, Dept. of Anesthesiology & Pain Medicine

Study Record Dates

• First Submitted: January 22, 2024
• First Posted: January 31, 2024
• Study Start: June 1, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: October 27, 2025

Record last verified: 2025-10

Locations

US (1)